Download Service Manual Maintenance

Service Manual
Maintenance
service code
revision
from SW rev.
date
6990576
A
3.36
March, 2009
Manufactured by:
GAMBRO DASCO S.p.A., Via Modenese 66, 41036 MEDOLLA (MO) Italy.
Questions or comments about this publication can be directed to your Local Representative.
© 2009 GAMBRO LUNDIA AB. All rights reserved.
PHOENIX is trademark of GAMBRO HOSPAL (Schweiz) AG and registered in: Australia,
Austria, Benelux, Denmark, Estonia, France, Georgia, Germany, Italy, Latvia, Lithuania,
Norway, Poland, Portugal, Republic of Moldova, Romania, Russian Federation, Slovakia,
Slovenia, Sweden, Turkey, United Kingdom, United States and in the European Community.
PHOENIX is a trademark of GAMBRO LUNDIA AB registered in Canada.
The logo
States.
is a trademark of GAMBRO HOSPAL Schweiz AG registered in the United
GAMBRO® is a registered trademark of GAMBRO LUNDIA AB.
HOSPAL® is a trademark of GAMBRO HOSPAL Schweiz AG and is registered in Algeria,
Austria, Belarus, Benelux, Bosnia-Herzegovina, Brazil, Bulgaria, Canada, China, Croatia, Czech
Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hungary, Italy, Japan,
Liechtenstein, Macedonia, Monaco, Morocco, Norway, North Korea, Poland, Portugal,
Romania, Russian Federation, San Marino, Slovak Republic, Slovenia, Spain, Sweden,
Switzerland, Ukraine, United Kingdom, United States, Vietnam, Yugoslavia.
Phoenix ® machine is protected by one or more of the following patents:
US4889635; US5276611; US5111683; US5590237; US5228889; US5567320; US5895578;
US4784495; US5024756; US4798090; US5041215; US5928177; US5609770; US5394732;
US5641144; US6811707; US6881344; US6794194; US5647984; US5733457; US5650071;
US5776091; US5624572; US5618441; US5629871; US5685835; US5948251; US6003556;
US5620608; US6468427; US6949214; US4740755;
EP0243284; EP0403401; EP0428676; EP0418171; EP0465381; EP0467805; EP0501894;
EP0658352; EP0813880; EP0900093; EP0330892; EP054702; EP0643301; EP0830155;
EP0830156; EP0831945; EP0836486; EP0830153; EP0835493;
CA1327022; CA2032156; CA2208931; CA1286284; CA1282012; CA1308569; CA1265403;
CA2016863;CA1253919;
JP2059115; JP3129326; JP3001235; JP2753242; JP3095223; JP3200594; JP1777042;
JP2542728; JP2823513;
IT1241624; IT01267416; IT01256865; IT01320264; IT01320247; AU595423; BR-PI88004392; KR094404; SE467142; SE465404; TW032116; DE-P3620743.8-35; DE4031613;
FR9014523; GB2239820; MX5077;
Phoenix ® machine is protected by one or more of the following design registrations:
US-D446861; US-D446860; US-D464060; US-D462698; US-D462362; US-D462696;
DM/051905; DM/055087; IT80564.
Certifications
Indicates that the equipment conforms to Council Directive
93/42/EEC, of 14 June, 1993 relating to Medical Devices.
Also indicates that the notified body which has approved the
manufacture’s quality system is the British Standards Institution (BSI).
Indicates that the equipment conforms to the rules related to the
Safety of Medical Electrical Equipment for U.S. and Canada.
The “C” and “US” indicator adjacent to the CSA mark signifies that
the product has been evaluated to the applicable ANSI/UL and CSA
Standards, for use in the U.S. and Canada.
This page is left intentionally blank
INTRODUCTION
I
INTRODUCTION
i.
INTRODUCTION
IEC Symbols
WARNING: Consult accompanying documents
TYPE B APPLIED PART
This apparatus provides an adequate degree of protection
against electric shock, particularly regarding allowable LEAKAGE
CURRENTS and reliability of the protective EARTH connection.
OFF (Mains power disconnected)
ON (Mains power connected)
Alternating current
Protective earth (ground)
This symbol indicates that:
- the equipment may not be disposed of together with other municipal
waste;
- the equipment was placed on the market after 13 August 2005.
Rev. A
II
PHOENIX SERVICE MANUAL: «MAINTENANCE»
Keep dry
Year of Manufacturing
Name and address of the Manufacturer
Serial Number
(from IEC 601.1)
User's Symbols
WARNING
.......
NOTE
......
Rev. A
Very important information related to the patient or operator
safety, or given to avoid the machine breaking down. Read
carefully before operating the machine.
Important information related to the correct operation of the
machine. Read carefully before operating the machine.
INTRODUCTION
III
INTENDED USE
This Phoenix® Hemodialysis delivery system is intended to be used to provide high flux and low flux
hemodialysis, hemofiltration and ultrafiltration on patients weighing 15 Kilograms or more. The Phoenix
system is to be used with either high or low permeability dialyzers. This device is intended to be used by
trained operators when prescribed by a physician, in a chronic care dialysis facility or acute care unit.
WARNING
Fluid balance deviations, even if within the specified Phoenix accuracy, can exceed a level
that can be tolerated by low-weight patients.
WARNING
The use of procedures not recommended by the manufacturer may result in patient injury
or death. The Manufacturer does not assume responsibility for patient safety if the
procedures described in this manual are not followed carefully and if staff who perform the
procedures have not been appropriately trained and are not qualified.
WARNING
It is responsibility of the physician to ensure that the appropriate dialyzer and Cartridge
Blood Set is selected for the weight of the patient being treated.
WARNING
This manual contains a number of references to accessories and disposables for use with
the Phoenix machine. The Phoenix machine has been tested and validated for use with the
accessories and disposables listed in this manual. The Manufacturer has not validated the
use of accessories or disposables other than those specified in this manual. The
Manufacturer does not assume responsibility or liability for use of accessories or disposable
other than those specified in this manual. It is the responsibility of the user to validate that
other accessories or disposables provide safe and effective performance.
SPARE PARTS
Note
The Manufacturer will maintain spare parts availability for ten years after the end of production of
PHOENIX. At the end of that time the involved product is considered obsolete and therefore it
must be disposed of according to local applicable regulations. The final user will be informed that
spare parts are no longer available through the technical service or the sales representative.
For additional information contact your local technical service representative.
Rev. A
IV
PHOENIX SERVICE MANUAL: «MAINTENANCE»
WARNINGS
WARNING
Do not assemble, install or use the machine before having read the Operator and Service
manuals.
WARNING
This operation must be carried out by authorized personnel; if not, the Manufacturer
cannot accept any responsibility for damage which may occur, and such damage is not
covered by the warranty.
WARNING
Check the continuity and the reliability of the ground connection.
WARNING
Verify the quality of the protective earth ground at installation.
WARNING
Do not perform any technical intervention on the machine from the dialysis preparation
phase until patient disconnection. Before performing any technical intervention on the
machine, are sure that it has been properly disinfected
WARNING
Do not use this machine near flammable gas or flammable anaesthetic mixtures with air,
with oxygen or with nitrous oxide.
WARNING
Storage under 0°C is only possible if the hydraulic circuit has been drained (see
Maintenance section of this Manual)
WARNING
This equipment conforms to IEC 60601-1-2 standard on Electromagnetic Compatibility;
thus it has an adequate degree of protection against electromagnetic disturbances.
However, to prevent any problem it is recommended not to use cellular phones (handheld) in the dialysis room or - at least - to keep a minimum distance of 10 m from the
equipment. Refer to local standards and guidelines.
WARNING
Possible hazards may arise from other equipment (different from the accessories listed in
the Operator Manual) being connected to the hemodialysis machine, which may cause the
maximum leakage current to be exceeded.
Rev. A
INTRODUCTION
V
WARNING
The correct installation of a MEDICAL ELECTRICAL SYSTEM requires that each SYSTEM
component be individually connected to the main power.
It is strongly recommended: NOT TO USE MULTIPLE PORTABLE SOCKET-OUTLETS.
However, if using multiple portable socket-outlets, they must comply with the IEC 60601-11 Standard and must NOT BE PLACED ON THE FLOOR.
WARNING
Wait at least 5 seconds between power off and power on cycles.
WARNING
Before moving the machine, check that the brake is released and remove infusion bags or
hanging objects from the IV pole.
WARNING
It is recommended to use concentrates which conform to the requirements of the local
standards or of the AAMI RD61 "Concentrates for hemodialysis" standard or of the
European Pharmaceutical standards.
The control of alarm thresholds and dialysate conductivity precision is of major medical
importance in ensuring a safe dialysis treatment.
WARNING
It is the responsibility of the user to determine the correspondence between the dialysate
conductivity, displayed by the machine, and the dialysate solute content, verified by clinical
laboratory results, for each dialysate concentrate used for dialysis treatment.
This can be done by taking dialysate samples at different conductivity values (e.g. 13,14,15
mS/cm) and sending them to a laboratory for analysis.
WARNING
Carefully read the BiCart® Instructions for Use before using the device. BiCart® may only
be used by staff, who are specially trained for hemodialysis treatments, using the Operator
Manual (see BiCart® paragraph).
WARNING
Only in the event of the “! CONCENTRATE TYPE ERROR: A PUMP or B PUMP or A&B
PUMPS” alarm is when it possible to perform the Autocalibration of PA or PB pump in
dialysis (see Maintenance Section) when the operator accesses the appropriate page by
pressing the MACHINE Tab.
Rev. A
VI
PHOENIX SERVICE MANUAL: «MAINTENANCE»
WARNING
In the case of Autocalibration of the Acetate or Bicarbonate pump, the user must verify that
the concentrate at the machine concentrate inlet is correct and confirm this by pressing the
Confirm button on the main keyboard.
The process will only proceed after this confirmation.
The use of incorrect concentrates can lead to an incorrect dialysate conductivity, not
detectable by the Protective System.
WARNING
If a bicarbonate dialysis was performed, do not turn off the machine with bicarbonate
dialysate fluid inside.
An acetic acid rinse must be performed at least twice a week to remove the calcium and
residues which may be deposited in the system during dialysis treatments.
WARNING
The use of the Cartridge Blood Tubing's Set designed for the machine is recommended to
guarantee safe and proper functioning of the system.
WARNING
Never insert fingers in the automatic clamp.
When the cover of the blood pump is open, verify that the pump is off.
WARNING
The Heparin Syringe diameters have been taken from samples from many countries and
are correct at the time of going to press. However, the manufacturer cannot be held
responsible for changes in syringe dimensions that may occur. The user should periodically
check the correlation between the stated and the actual diameters.
WARNING
For the BPM installation, carefully follow the instructions supplied with the BPM kit.
WARNING
The BPM must only be used for adult patients with a body weight greater than 15 Kg and
using a BPM cuff of the appropriate size.
Avoid squeezing or kinking of pressure tubes.
The BPM should be tested at least once every 4000 hours, or any time irregular
performance is suspected or observed.
Insulating material protects the BPM "Applied Part" (Type BF) against the effects of a
defibrillator discharge.
If the cuff or the pneumatic connections gets wet, wipe immediately to prevent moisture
entering the machine.
Rev. A
INTRODUCTION
VII
WARNING
In order to fully comply with the indications of the European Medical Device Directive
93/42, the user is notified that the information originating from the BPM cannot be used
alone as a unique source of information to induce any therapeutical or pharmacological
actions.
WARNING
To prevent damaging the machine, do not leave disinfectant solution in the machine
during the ADR CHEMICAL DISINFECTION procedure for periods over the following
limits:
4 hrs for: Amuchina™, Instrunet HD™ and Sodium Hypochlorite at Disinfectant strength
(1:25 dilution);
24 hrs for: Dialox™, Acetoper™, Peresal™, Actril® and Renalin®;
48 hrs for: formaldehyde solution and Steridial™;
One week for: Sodium Hypochlorite at Bacteriostatic strength (1:750 dilution).
WARNING
When the DiaClear ultrafilter is installed, the CHEMICAL DISINFECTION must only be
performed with an approved disinfectant in order not to damage the DiaClear ultrafilter.
WARNING
For the disinfection of the ultrafilter it is mandatory to use only the chemical agents
recommended in the DiaClear Instructions for Use, compatible with the equipment. The
maximum concentration allowed for the disinfectant used is:
6% Sodium Hypochlorite
4% Peracetic acid
40% Formaldehyde
100% Instrunet
100% Steridial
Refer to the DiaClear Instructions for Use.
Some solvents or other chemical products used for cleaning can damage the DiaClear
ultrafilter: Refer to the DiaClear Instructions for Use for the list of non validated products.
WARNING
The user must take precautions against the hazard of cross-infection between patients by
disinfecting the accessible surfaces of the equipment.
WARNING
Do not use chemicals which might damage the plastic parts of the machine .
Avoid chemicals containing benzene, toluene, xylene, acetone or similar solvents.
WARNING
Any fluid spilled on the machine must immediately be cleaned to prevent it from getting
into the machine.
Rev. A
VIII PHOENIX SERVICE MANUAL: «MAINTENANCE»
Tables of Contents
INTRODUCTION …………………………………………………………………………………………………………………………………I
IEC Symbols ........................................................................................................................................................... I
User's Symbols ..................................................................................................................................................... II
INTENDED USE ..................................................................................................................................................III
SPARE PARTS ......................................................................................................................................................III
WARNINGS........................................................................................................................................................ IV
Tables of Contents........................................................................................................................................... VIII
SERVICE INFORMATION ……………………………………………………………………………………………………………………..I
1. SYSTEM DESCRIPTION ………………………………………………………………………………………………………………….1-1
1.1 Machine Overview....................................................................................................................................1-1
1.1.1 Therapies Description ..............................................................................................................1-1
1.1.2 Structure of the machine .........................................................................................................1-2
1.1.2.1 Master Module........................................................................................................ 1-2
1.1.2.2 Hydraulic Module................................................................................................... 1-2
1.1.2.3 Blood Module ......................................................................................................... 1-3
1.1.2.3.1 CONTROL SYSTEM....................................................................... 1-3
1.1.2.4 Protection Module ................................................................................................. 1-3
1.1.2.5 BIO Module............................................................................................................. 1-3
1.2 Description of the machine .....................................................................................................................1-4
1.2.1 Front view ...................................................................................................................................1-4
1.2.2 Front Panel Machine Components........................................................................................1-5
1.2.3 Rear view ....................................................................................................................................1-7
1.2.4 Rear Machine Components ....................................................................................................1-8
1.3 Operator Interface.................................................................................................................................. 1-10
1.3.1 Patient Card Reader............................................................................................................... 1-10
1.3.2 Screen Description................................................................................................................. 1-10
1.3.3 Icons shown in “Icon Area” ................................................................................................. 1-12
1.3.4 HOME icons............................................................................................................................ 1-14
1.3.5 Pictograms ............................................................................................................................... 1-15
1.3.5.1 Background shape................................................................................................1-15
1.3.5.2 List of Pictograms..................................................................................................1-16
1.3.6 Help messages in Idle mode................................................................................................ 1-21
1.4 Control Panels ......................................................................................................................................... 1-25
1.5 Blood Circuit Description ..................................................................................................................... 1-27
1.5.1 Venous and arterial pressure sensors................................................................................. 1-27
1.5.2 Blood Pump ............................................................................................................................ 1-27
1.5.3 Blood Pump Door with door sensor .................................................................................. 1-27
1.5.4 Air bubble detector................................................................................................................ 1-27
1.5.5 Patient Sensor ......................................................................................................................... 1-28
1.5.6 Venous patient tubing presence sensor in Air Bubble Detector .................................. 1-28
1.5.7 Venous patient line clamp.................................................................................................... 1-28
1.5.8 Arterial line clamp (optional) ............................................................................................... 1-28
1.5.9 Venous patient tubing presence sensor in venous clamp ............................................. 1-28
1.5.10 Heparin Pump ...................................................................................................................... 1-28
1.5.11 Saline line clamp .................................................................................................................. 1-28
1.5.12 Blood Cartridge.................................................................................................................... 1-29
1.5.12.1 Blood circuit: front view....................................................................................1-29
1.5.12.2 Cassette................................................................................................................1-30
1.5.12.3 Blood Pressure Transducers .............................................................................1-31
1.6 Automatic or Manual Priming .............................................................................................................. 1-32
Rev. A
INTRODUCTION
IX
1.7 Ultrafiltration Control-Mass Balance....................................................................................................1-33
1.8 Temperature Control and Monitoring ................................................................................................1-33
1.9 Conductivity Control and Monitoring ................................................................................................1-34
1.9.1 Bicarbonate Concentrate Preparation................................................................................1-34
1.9.2 Bicarbonate Concentrate Mixing.........................................................................................1-34
1.9.3 Bicarbonate Temperature Control and Protective ...........................................................1-34
1.9.4 Bicarbonate Conductivity Control and Protective ...........................................................1-34
1.9.5 BiCart® Option.......................................................................................................................1-35
1.9.6 Acid Concentrate Preparation .............................................................................................1-35
1.9.7 Acid Concentrate Mixing ......................................................................................................1-35
1.9.8 Acid Temperature Control and Protective.........................................................................1-35
1.9.9 Acid Conductivity Control and Protective.........................................................................1-35
1.9.10 Acetate Concentrate Preparation .....................................................................................1-35
1.10 Disinfection and Rinse .........................................................................................................................1-36
1.10.1 List of ADR Parameters and their meanings ...................................................................1-37
2. HYDRAULIC DESCRIPTION …………………………………………………………………………………………………………..2-1
2.1
2.2
2.3
2.4
Hydraulic Circuit Description ................................................................................................................. 2-1
Water Supply Connection and Filtering ............................................................................................... 2-1
Inlet Water Pressure Control .................................................................................................................. 2-2
Heating and deaeration ........................................................................................................................... 2-2
2.4.1 Heat Exchanger......................................................................................................................... 2-3
2.4.2 Restrictor Bypass Valve ........................................................................................................... 2-3
2.4.3 Heater (HB),Thermocouple/Temperature sensor (STH) ................................................... 2-3
2.4.3.1 Heater Temperature Sensor (TP) ........................................................................ 2-3
2.4.4 Deaeration ................................................................................................................................. 2-4
2.4.5 Degassing restrictor (OR2) ..................................................................................................... 2-4
2.5 Concentrate mixing and conductivity control ..................................................................................... 2-5
2.5.1 Bicarbonate Concentrate Mixing........................................................................................... 2-5
2.5.1.1 Bicarbonate Temperature Control Sensor (Tc) and Protective
Sensor (Tp) ............................................................................................................................ 2-6
2.5.1.2 Bicarbonate Conductivity Control Sensor (ΓcB) and Protective
Sensor (ΓpB) ......................................................................................................................... 2-6
2.5.1.3 BiCart Option.......................................................................................................... 2-6
2.5.2 Acid Concentrate Preparation ............................................................................................... 2-7
2.5.2.1 Acid Concentrate Mixing...................................................................................... 2-7
2.5.2.2 Acid Temperature Control and Protective Sensors......................................... 2-7
2.5.2.3 Acid Conductivity Control and Protective Sensors ......................................... 2-7
2.5.2.4 Acetate Concentrate Preparation ....................................................................... 2-7
2.5.3 Final Deaeration........................................................................................................................ 2-8
2.5.4 Final Temperature Monitor..................................................................................................... 2-8
2.5.5 pH Sensor (pH) ......................................................................................................................... 2-8
2.6 UF and Flow Control ................................................................................................................................ 2-9
2.6.1 Clean Dialysate .......................................................................................................................2-10
2.6.2 Pre-Dialyzer pressure .............................................................................................................2-10
2.6.3 Dialyzer.....................................................................................................................................2-10
2.6.4 Dialyzer Bypass Block............................................................................................................2-11
2.6.5 P2 Pump and Pd pressure sensor........................................................................................2-11
2.6.6 Taration.....................................................................................................................................2-11
2.6.7 Post-Dialyzer Bubble Trap (BT2)..........................................................................................2-11
2.6.8 Blood Leak Detector (BLD) ..................................................................................................2-12
2.6.9 Ultrafiltration Control.............................................................................................................2-12
2.6.10 Effluent Removal...................................................................................................................2-12
2.7 Diascan......................................................................................................................................................2-13
2.8 Waste Handling Option (WHO)..........................................................................................................2-14
2.9 ADR ...........................................................................................................................................................2-15
Rev. A
X
PHOENIX SERVICE MANUAL: «MAINTENANCE»
2.9.1 Chemical Disinfection (from front port) ............................................................................ 2-15
2.9.2 Heat Disinfection with Citric Acid ...................................................................................... 2-16
2.9.3 Disinfection with Permanent Connected Containers ..................................................... 2-16
2.10 Phoenix Hydraulic circuit.................................................................................................................... 2-17
2.11 Component legend .............................................................................................................................. 2-21
2.12 Phoenix Pressure map ......................................................................................................................... 2-25
2.13 Hydraulic Location............................................................................................................................... 2-29
2.13.1 Rear View................................................................................................................2-29
2.13.2 Front Valves Group ...............................................................................................2-30
2.13.3 Pumps and Conductivity Cells ............................................................................2-31
2.13.4 UF Circuit and Sterilant Line................................................................................2-32
2.13.5 Heat System and D1 Flow Meter.......................................................................2-33
3. HYDRAULIC PHASE DESCRIPTION ……………………………………………………………………………………………….3-1
3.1 Dialysis process..........................................................................................................................................3-1
3.1.1 Dialysis Phases...........................................................................................................................3-2
3.1.2 Dialysis: phase 32 – End of Process (IDLE) ..........................................................................3-4
3.1.3 Dialysis: phase 7 – Filling the Circuit for Pi and Po test ....................................................3-6
3.1.4 Dialysis: phase 1 – Emptying of residual water from Disinfectant Tank.........................3-8
3.1.5 Dialysis: phase 2 – Rinsing The Main Hydraulic Circuit ................................................. 3-10
3.1.6 Dialysis: phase 3 – Rinsing the Main Hydraulic Circuit.................................................. 3-12
3.1.7 Dialysis: phase 4 – Emptying the Circuit ........................................................................... 3-14
3.1.8 Dialysis: phase 5 – Filling the circuit with water .............................................................. 3-16
3.1.9 Dialysis: phase 6 - Dialysate preparation: Temp. And Cond. Regulation.................... 3-18
3.1.10 Dialysis: phase 8 – Dialysate preparation ....................................................................... 3-20
3.1.11 Dialysis: phase 9A – P2 Pump checking ......................................................................... 3-22
3.1.12 Dialysis: phase 9B – UF Pump checking......................................................................... 3-24
3.1.13 Dialysis: phase 10 – Flow-meter Calibration .................................................................. 3-26
3.1.14 Dialysis: phase 11 – Wait for Hemodialyzer connection ............................................ 3-28
3.1.15 Dialysis: phase 11bis – BYPASS due to an alarm condition........................................ 3-30
3.1.16 Dialysis: phase 12A – HD Connection............................................................................ 3-32
3.1.17 Dialysis: phase 12B – Calibration ..................................................................................... 3-34
3.1.18 Dialysis: phase 13 – Filling and Rinsing the Hemodialyzer (Hydraulic p.) .............. 3-36
3.1.19 Dialysis: phase 14 – Hydr. Priming end and Wait for patient..................................... 3-38
3.1.20 Dialysis: phase 15 – Wait for Patient when the machine is in Bypass ...................... 3-40
3.1.21 Dialysis: phase 16 – Patient Connection ........................................................................ 3-42
3.1.22 Dialysis: phase 17 – Start Dialysis .................................................................................... 3-44
3.1.23 Dialysis: phase 18 – Flow-meters Calibration ................................................................ 3-46
3.1.24 Dialysis: phase 19 – Dialysis.............................................................................................. 3-48
3.1.25 Dialysis: phase 20 – BY-PASS = UF ONLY (operator).................................................. 3-50
3.1.26 Dialysis: phase 21 – Flow-meter Calibration .................................................................. 3-52
3.1.27 Dialysis: phase 22 – UF-ONLY set by the Protective System ..................................... 3-54
3.1.28 Dialysis: phase 23 – Filling and rinsing the hemodialyzer in case of filter
replacement during the treatment ................................................................................................ 3-56
3.1.29 Dialysis: phase 24 – Hydraulic Priming end in case of filter replacement
during the treatment ........................................................................................................................ 3-58
3.1.30 Dialysis: phase 25 – Ultrafilter tangential rinsing........................................................... 3-60
3.1.31 Dialysis: phase 27 – Blood Restitution ............................................................................ 3-62
3.1.32 Dialysis: phase 28 – Emptying the Hemodialyzer......................................................... 3-64
3.1.33 Dialysis: phase 29 – End of session and Rinsing ........................................................... 3-66
3.1.34 Dialysis: phase 30 – Descaling.......................................................................................... 3-68
3.1.35 Dialysis: phase 30A– Descaling with AUTOEMPTYING ............................................. 3-70
3.1.36 Dialysis: phase 31A – PI, PO > +500 mmHg (Restart condition)............................... 3-72
3.1.37 Dialysis: phase 31 – PI, PO < -450 mmHg (Restart condition)................................... 3-74
3.1.38 Dialysis: phase 31B – Hemodialyzer connectors in bad position.............................. 3-76
3.1.39 Dialysis: phase 31C – No Water ...................................................................................... 3-78
3.1.40 Dialysis: phase 33 – BY-PASS due to alarm during priming phase ............................ 3-80
Rev. A
INTRODUCTION
XI
3.2 Rinsing Process ........................................................................................................................................3-82
3.2.1 Rinsing: phase 2 - Tangential Ultrafilter rinsing .................................................................3-84
3.2.2 Rinsing: phase 3 - Rinsing main circuit + test air on HLS, LLS, HLUF, LLUF ...............3-86
3.2.3 Rinsing: phase 4 - Test air on LP, LD1 ................................................................................3-88
3.2.4 Rinsing: phase 5 - Test water on LP, LD1...........................................................................3-90
3.2.5 Rinsing: phase 6 – Rinsing main circuit + test water on LLUF, HLUF ..........................3-92
3.2.6 Rinsing: phase 7 – Emptying DH-tank (only on failure of phase 6) ..............................3-94
3.2.7 Rinsing: phase 8 – Rinsing external bypass .......................................................................3-96
3.2.8 Rinsing: phase 9 – Rinsing EVD2 + UF...............................................................................3-98
3.2.9 Rinsing: phase 10 – Rinsing EVR1 + EVW2.................................................................... 3-100
3.2.10 Rinsing: phase 11 – Rinsing EVR1 + EVW1 ................................................................. 3-102
3.2.11 Rinsing: phase 12 – Rinsing EVR1 + EVD1 .................................................................. 3-104
3.2.12 Rinsing: phase 13 – Rinsing EVR1 + EVP...................................................................... 3-106
3.2.13 Rinsing: phase 14A – Rinsing Ultrafilter (+ emptying DT_tank only if last
phase)............................................................................................................................................... 3-108
3.2.14 Rinsing: phase 14B – Rinsing Ultrafilter (+ emptying DT_tank only if last
phase)............................................................................................................................................... 3-110
3.2.15 Rinsing: phase 15 – End phase ....................................................................................... 3-112
3.2.16 Rinsing: phase 16 – Deflating phase (only on operator STOP or if
parameter AUTO-SWITCH OFF is YES) .................................................................................... 3-114
3.2.17 CCK Rinsing: phase 1 – Rinsing the Central Bicarbonate Line and the
Central Acid Line (A1 or A2) ....................................................................................................... 3-116
3.2.18 CCK Rinsing: phase 2 – End of process........................................................................ 3-118
3.2.19 CCK Rinsing: phase 3 – Deflating phase (only on operator STOP) ........................ 3-120
3.3 Chemical disinfection.......................................................................................................................... 3-122
3.3.1 Chemical Disinfection: phase 1 - Empting DT_tank + rinsing main circuit............... 3-124
3.3.2 Chemical Disinfection: phase 2A - Filling DT_tank (through SWD) + rinsing
main circuit...................................................................................................................................... 3-126
3.3.3 Chemical Disinfection: phase 2B - Filling DT_tank (through jug 1) + rinsing
main circuit...................................................................................................................................... 3-128
3.3.4 Chemical Disinfection: phase 2C - Filling DT_tank (through jug 2) + rinsing
main circuit...................................................................................................................................... 3-130
3.3.5 Chemical Disinfection: phase 3 - Disinfecting the EVR1 line...................................... 3-132
3.3.6 Chemical Disinfection: phase 4 - Disinfecting the EVW1 line .................................... 3-134
3.3.7 Chemical Disinfection: phase 5 - Disinfecting the EVW2 line .................................... 3-136
3.3.8 Chemical Disinfection: phase 6 - Disinfecting the lines above BTP and BT1 .......... 3-138
3.3.9 Chemical Disinfection: phase 7 - Disinfecting the lines above BT2........................... 3-140
3.3.10 Chemical Disinfection: phase 8 - Disinfecting Ultrafilter ........................................... 3-142
3.3.11 Chemical Disinfection: phase 9 - Disinfecting the bypass line ................................. 3-144
3.3.12 Chemical Disinfection: phase 10 - Disinfecting the main circuit ............................. 3-146
3.3.13 Chemical Disinfection: phase 11 - Preparing the Bacteriostatic solution in
DT_tank ........................................................................................................................................... 3-148
3.3.14 Chemical Disinfection: phase 12 - Filling of water the DT_tank .............................. 3-150
3.3.15 Chemical Disinfection: phase 13 - Empting the DT_tank through the EVR1
loop................................................................................................................................................... 3-152
3.3.16 Chemical Disinfection: phase 14 - Final Emptying the DT_tank .............................. 3-154
3.3.17 Chemical Disinfection: phase 15 - Emergency phase in case of heater
protection failing ............................................................................................................................ 3-156
3.3.18 Chemical Disinfection: phase 16 - End of process ..................................................... 3-158
3.3.19 Chemical Disinfection: phase 17 - Deflating phase.................................................... 3-160
3.3.20 Integrated Chemical Disinfection: phase 1 - Disinfecting the EVR1 line +
P2 +UF ............................................................................................................................................. 3-162
3.3.21 Integrated Chemical Disinfection: phase 2 - Disinfecting the EVW1, EVR1
lines + UF......................................................................................................................................... 3-164
3.3.22 Integrated Chemical Disinfection: phase 3 - Disinfecting the EVW2, EVR1
lines + UF......................................................................................................................................... 3-166
3.3.23 Integrated Chemical Disinfection: phase 4 - Disinfecting the EVP, EVD1
lines................................................................................................................................................... 3-168
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XII PHOENIX SERVICE MANUAL: «MAINTENANCE»
3.3.24 Integrated Chemical Disinfection: phase 5 - Disinfecting the EVD2
line + UF..........................................................................................................................................3-170
3.3.25 Integrated Chemical Disinfection: phase 6 - Disinfecting the EVBP line ..............3-172
3.3.26 Integrated Chemical Disinfection: phase 7 - Disinfecting the Bypass line..............3-174
3.3.27 Integrated Chemical Disinfection: phase 8 - Disinfecting the main circuit.............3-176
3.3.28 Integrated Chemical Disinfection: phase 9 - Last phase ............................................3-178
3.3.29 Integrated Chemical Disinfection: phase 10 - Deflating phase.................................3-180
3.4 Heat disinfection...................................................................................................................................3-182
3.4.1 Heat Disinfection: phase 1 - Rinsing EVP, EV2 lines .....................................................3-184
3.4.2 Heat Disinfection: phase 2 – Loop PC, Loop PO, EVD1, EVD2 lines, Bypass ........3-186
3.4.3 Heat Disinfection: phase 3 – Rinsing EV1, EVW1, EVW2 lines ..................................3-188
3.4.4 Heat Disinfection: phase 4 – Rinsing EVBP and UF burette .......................................3-190
3.4.5 Heat Disinfection: phase 5 – Rinsing Loop PC, Loop EVR1, Loop PO,
Bypass...............................................................................................................................................3-192
3.4.6 Heat Disinfection: phase 6 – Rinsing Loop PC, Loop EVR1, Loop PO,
Bypass...............................................................................................................................................3-194
3.4.7 Heat Disinfection: phase 7 – Rinsing EV2 line and UF burette external line ...........3-196
3.4.8 Heat Disinfection: phase 8 - Heating water....................................................................3-198
3.4.9 Heat Disinfection: phase 9 - Disinfecting the BTP line + EVR1...................................3-200
3.4.10 Heat Disinfection: phase 10 - Disinfecting the line above BT1 + EVR1..................3-202
3.4.11 Heat Disinfection: phase 11 - Disinfecting the EVW2 line ........................................3-204
3.4.12 Heat Disinfection: phase 12 - Disinfection the EVW1................................................3-206
3.4.13 Heat Disinfection: phase 13 - Disinfecting bypass + UF............................................3-208
3.4.14 Heat Disinfection: phase 14 - Tangential disinfection of the Ultrafilter + UF .......3-210
3.4.15 Heat Disinfection: phase 15 - Disinfecting the line above BT2 + Ultrafilter...........3-212
3.4.16 Heat Disinfection: phase 16 – Disinfecting P2 + UF ..................................................3-214
3.4.17 Heat Disinfection: phase 17 - Cooling the main circuit .............................................3-216
3.4.18 Heat Disinfection: phase 18 - Heating phase in case of temperature drop...........3-218
3.4.19 Heat Disinfection: phase 19 - End of process ..............................................................3-220
3.4.20 Heat Disinfection: phase 20 - Deflating phase ............................................................3-222
3.5 Heat citric disinfection.........................................................................................................................3-224
3.5.1 Heat Citric Disinfection: phase 1 - Rinsing Loop PC, Loop EVR1, Loop PO,
Bypass, PA and PB Pumps............................................................................................................3-226
3.5.2 Heat Citric Disinfection: phase 2 – Rinsing Loop PC, Loop EVR1, Loop PO,
Bypass, PA and PB .........................................................................................................................3-228
3.5.3 Heat Citric Disinfection: phase 3 – Rinsing EV2 line + external line UF
burette ..............................................................................................................................................3-230
3.5.4 Heat Citric Disinfection: phase 4 – Rinsing EVBP line + UF burette .........................3-232
3.5.5 Heat Citric Disinfection: phase 5 – Rinsing EVP, EV2 ..................................................3-234
3.5.6 Heat Citric Disinfection: phase 6 – Rinsing Loop PC, EVD2 line, EVD1 line,
Loop PO...........................................................................................................................................3-236
3.5.7 Heat Citric Disinfection: phase 7 – Rinsing EV1, EVW1, EVW2 lines .......................3-238
3.5.8 Heat Citric Disinfection: phase 8A – Filling the disinfectant tank
(If LIQUID FROM =REAR 1 ) .......................................................................................................3-240
3.5.9 Heat Citric Disinfection: phase 8B – Filling the disinfectant tank
(If LIQUID FROM =REAR 2 ) .......................................................................................................3-242
3.5.10 Heat Citric Disinfection: phase 9 – Heating and filling the disinfectant tank
(if LIQUID FROM =FRONT ) .......................................................................................................3-244
3.5.11 Heat Citric Disinfection: phase 10 - Disinfecting EVP, Loop EVR1, PA and
PB ......................................................................................................................................................3-246
3.5.12 Heat Citric Disinfection: phase 11 - Disinfecting EVD1 and Loop EVR1 ...............3-248
3.5.13 Heat Citric Disinfection: phase 12 - Disinfecting EVW2, Loop EVR1, UF
burette, PA and PB.........................................................................................................................3-250
3.5.14 Heat Citric Disinfection: phase 13 - Disinfecting EVW1, Loop EVR1, UF
burette ..............................................................................................................................................3-252
3.5.15 Heat Citric Disinfection: phase 14 – Disinfecting Bypass + external line UF
burette ..............................................................................................................................................3-254
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INTRODUCTION
XIII
3.5.16 Heat Citric Disinfection: phase 15 - Disinfecting EVBP + Ultrafilter +
external line UF burette ................................................................................................................ 3-256
3.5.17 Heat Citric Disinfection: phase 16 – Disinfecting EVD2, Ultrafilter, P2 ................. 3-258
3.5.18 Heat Citric Disinfection: phase 17 – Disinfecting the main circuit ......................... 3-260
3.5.19 Heat Citric Disinfection: phase 18 – Rinsing EVP, EV1, PA and PB........................ 3-262
3.5.20 Heat Citric Disinfection: phase 19 – Rinsing EVD1, EVR1, PA and PB .................. 3-264
3.5.21 Heat Citric Disinfection: phase 20 – Rinsing EVBP, PA and PB............................... 3-266
3.5.22 Heat Citric Disinfection: phase 21 – Rinsing the external Bypass line +
UF, PA and PB ................................................................................................................................ 3-268
3.5.23 Heat Citric Disinfection: phase 22 – Rinsing main circuit + P2 +
UF external line, EVD2, EVHE, PA and PB ................................................................................ 3-270
3.5.24 Heat Citric Disinfection: phase 23 – Rinsing Loop EVR1, EVW2, PA and PB....... 3-272
3.5.25 Heat Citric Disinfection: phase 24 – Rinsing Loop EVR1, EVW1, PA and PB....... 3-274
3.5.26 Heat Citric Disinfection: phase 25 – Rinsing main circuit + P2 + UF ..................... 3-276
3.5.27 Heat Citric Disinfection: phase 26 – Heating phase in case of temperature
drop .................................................................................................................................................. 3-278
3.5.28 Heat Citric Disinfection: phase 27 – End of process ................................................. 3-280
3.5.29 Heat Citric Disinfection: phase 28 – Deflating phase................................................ 3-282
4. BLOOD CIRCUIT DESCRIPTION …………………………………………………………………………………………………..4-1
4.1 Introduction................................................................................................................................................ 4-1
4.2 Blood Cartridge Set................................................................................................................................... 4-1
4.2.1 Blood Module: Double Needle ............................................................................................. 4-2
4.2.2 Blood Circuit Diagram: Double Needle............................................................................... 4-3
4.2.3 Dialyzer & Connections .......................................................................................................... 4-4
4.3 Saline line clamp........................................................................................................................................ 4-4
4.4 Arterial Access Port................................................................................................................................... 4-4
4.5 Venous Access Port.................................................................................................................................. 4-4
4.6 Venous and Arterial Pressure Sensors................................................................................................... 4-5
4.7 Blood Pump................................................................................................................................................ 4-5
4.8 Blood Pump Door with door sensor ..................................................................................................... 4-6
4.9 Blood Pump Rotor, Raceway, & Rotor Position Hall Sensors .......................................................... 4-6
4.10Air bubble detector ................................................................................................................................. 4-6
4.10.1 Ultrasonic Oscillator and Transmitter Output .................................................................. 4-7
4.10.2 Ultrasonic Receiver Output ................................................................................................. 4-7
4.11 Patient Sensor.......................................................................................................................................... 4-7
4.12 Venous tubing presence switch in Air Bubble Detector................................................................. 4-8
4.13 Venous clamp.......................................................................................................................................... 4-8
4.14 Venous tubing presence switch in venous clamp ............................................................................ 4-8
4.15 Heparin Pump ......................................................................................................................................... 4-9
4.16 Additional Blood Circuit Information................................................................................................4-10
4.16.1 Blood Pump Control Panel.................................................................................................4-10
4.16.2 Blood Pump flow and Ultrafiltration.................................................................................4-10
4.17 Single Needle Clamp Assembly .........................................................................................................4-11
4.17.1 Blood Module: Single Needle............................................................................................4-12
4.17.2 Blood Circuit Diagram: Single Needle .............................................................................4-13
5. ELECTRONIC DESCRIPTION …………………………………………………………………………………………………………5-1
5.1 Main Board................................................................................................................................................. 5-1
5.1.1 Flash Memory............................................................................................................................ 5-2
5.1.2 Liquid Crystal Display and Touch Screen ............................................................................ 5-2
5.1.3 Patient Card ............................................................................................................................... 5-2
5.1.4 CDROM ..................................................................................................................................... 5-2
5.1.5 RS485 Board.............................................................................................................................. 5-3
5.1.6 Ethernet Connection ................................................................................................................ 5-3
5.1.7 BPM Module ............................................................................................................................. 5-3
5.2 Control/Protective Systems..................................................................................................................... 5-3
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XIV PHOENIX SERVICE MANUAL: «MAINTENANCE»
5.2.1 SPI Communication Bus ..........................................................................................................5-3
5.3 Blood Slave Board .....................................................................................................................................5-5
5.3.1 SPI Communication Bus ..........................................................................................................5-5
5.3.2 Blood Pump ...............................................................................................................................5-5
5.3.3 Blood Pump Encoder ...............................................................................................................5-5
5.3.4 Blood Pump Door Sensor .......................................................................................................5-5
5.3.5 Blood Pump Rotor and Direction Hall Sensors...................................................................5-5
5.3.6 Venous Clamp ...........................................................................................................................5-6
5.3.7 Arterial and Venous Pressure Transducers...........................................................................5-6
5.3.8 Heparin Pump............................................................................................................................5-6
5.3.9 Heparin Pump Encoder............................................................................................................5-6
5.3.10 Heparin Pump Limit Switches ..............................................................................................5-6
5.3.11 Blood Pressure Monitor (BPM) ............................................................................................5-6
5.4 Hydraulic Slave Board ........................................................................................................................... 5-11
5.4.1 SPI Communication Bus ....................................................................................................... 5-11
5.4.2 Water Inlet Pressure Switch (SWP)..................................................................................... 5-11
5.4.3 Inlet Water Valve (EVH2O).................................................................................................. 5-11
5.4.4 Heater Flow Switch (LFP) ..................................................................................................... 5-11
5.4.5 Dialysate Flow Switch (LFD) ................................................................................................ 5-11
5.4.6 Drain Pressure Switch (SWP1) ............................................................................................ 5-11
5.4.7 Deaeration Pump (PC).......................................................................................................... 5-12
5.4.7.1 PC Pump Encoder (FPC) .....................................................................................5-12
5.4.8 Flow Pump (P1) ...................................................................................................................... 5-12
5.4.8.1 P1 Pump Encoder (FP1) ......................................................................................5-12
5.4.9 Flow Pump (P2) ...................................................................................................................... 5-12
5.4.9.1 P2 Pump Encoder (FP2) ......................................................................................5-12
5.4.10 D1 Flowmeter (FD1) ........................................................................................................... 5-12
5.4.11 D2 Flowmeter (FD2) ........................................................................................................... 5-13
5.4.12 PD Drain Pressure Sensor .................................................................................................. 5-13
5.4.13 PO Pressure Sensor............................................................................................................. 5-13
5.4.14 PI Pressure Sensor ............................................................................................................... 5-13
5.4.15 PFS Pressure Sensor ............................................................................................................ 5-13
5.4.16 Ultrafiltration Pump (PUF).................................................................................................. 5-13
5.4.16.1 UF Burette (UFT) Level Sensors (HLUF, LLUF) .............................................5-14
5.4.17 Concentrate Pumps (PB) and (PA) ................................................................................... 5-14
5.4.18 Conductivity Cells (CCA, CCB, PCA, PCB) .................................................................... 5-14
5.4.19 Sterilant Pump (PS) Level Sensors (HLS, LLS, HLUF, LLUF)......................................... 5-15
5.4.20 Level Sensors (LP, LD1, LD2) ............................................................................................ 5-15
5.4.21 Heater (HB) Temperature Sensors (TP, TPS) Thermocouple/Temperature
sensor (STH) ...................................................................................................................................... 5-15
5.5 Protective Slave Board .......................................................................................................................... 5-25
5.5.1 Air Bubble Detector............................................................................................................... 5-25
5.5.2 Venous Clamp Line Sensor .................................................................................................. 5-25
5.5.3 Venous Line Presence Sensor.............................................................................................. 5-25
5.5.4 Blood Leak Detector ............................................................................................................. 5-25
5.5.5 pH Probe ................................................................................................................................. 5-26
5.5.6 Patient Sensor ......................................................................................................................... 5-26
5.6 Bioslave Board......................................................................................................................................... 5-31
5.7 Blood Pump Board ................................................................................................................................. 5-31
5.8 PIB Board.................................................................................................................................................. 5-31
6. SIGNALS & CONNECTIONS DESCRIPTION …………………………………………………………………………………..6-1
6.1 MOTHER BOARD LAY OUT from Rev. A0 .........................................................................................6-1
6.2 MOTHER BOARD SIGNAL LIST from Rev. A0 ...................................................................................6-5
6.2.1 Rev. A0........................................................................................................................................6-5
6.2.2 Rev. B0 or greater .....................................................................................................................6-7
6.3 Signals Description ................................................................................................................................. 6-17
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INTRODUCTION
XV
6.4 Circuit Boards Description ....................................................................................................................6-25
6.4.1 Protective Board EMC (6969141).......................................................................................6-25
6.4.2 Hydraulic Slave Board (6969125) .......................................................................................6-26
6.4.3 Blood Slave Board (6969109)..............................................................................................6-28
6.4.4 Bioslave Board (code 6970362 and 6971055) ................................................................6-30
6.4.5 CARRIER 1 (6967772)..........................................................................................................6-32
6.4.6 DTY-MONITOR board (6973028) ......................................................................................6-33
6.4.7 PC 104 Pentium......................................................................................................................6-34
6.4.8 HDBPM Board (6963839)...................................................................................................6-35
6.4.9 CPC SMD Board (6965545).................................................................................................6-36
6.5 Mother Board Connectors Description..............................................................................................6-37
6.5.1 Connector J1 Mother Board.................................................................................................6-37
6.5.2 Connector J2 Mother Board.................................................................................................6-37
6.5.3 Connector J3 Mother Board.................................................................................................6-38
6.5.4 Connector J4 Mother Board.................................................................................................6-38
6.5.5 Connector J5 Mother Board.................................................................................................6-38
6.5.6 Connector J6 Mother Board.................................................................................................6-39
6.5.7 Connector J7 Mother Board.................................................................................................6-39
6.5.8 Connector J8 Mother Board.................................................................................................6-39
6.5.9 Connector J9 Mother Board.................................................................................................6-40
6.5.10 Connector J10 Mother Board............................................................................................6-40
6.5.11 Connector J12 Mother Board............................................................................................6-40
6.5.12 Connector J13 Mother Board............................................................................................6-40
6.5.13 Connector J14 Mother Board............................................................................................6-41
6.5.14 Connector J15 Mother Board............................................................................................6-41
6.5.15 Connector J18 Mother Board............................................................................................6-42
6.5.16 Connector J19 Mother Board............................................................................................6-42
6.5.17 Connector J20 Mother Board............................................................................................6-43
6.5.18 Connector J21 Mother Board............................................................................................6-43
6.5.19 Connector J32 Mother Board............................................................................................6-44
6.5.20 Connector J34 Mother Board............................................................................................6-44
6.5.21 Connector J35 Mother Board............................................................................................6-45
6.5.22 Connector J36 Mother Board............................................................................................6-46
6.5.23 Connector J36/2 Mother Board........................................................................................6-47
6.5.24 Connector J36/3 Mother Board........................................................................................6-47
6.5.25 Connector J37 Mother Board............................................................................................6-48
6.5.26 Connector J38 Mother Board............................................................................................6-48
6.5.27 Connector J39 Mother Board............................................................................................6-48
6.5.28 Connector J41 Mother Board............................................................................................6-48
6.5.29 Connector J42 Mother Board............................................................................................6-49
6.5.30 Connector J43 Mother Board............................................................................................6-49
6.5.31 Connector J45 Mother Board............................................................................................6-50
6.5.32 Connector J46 Mother Board............................................................................................6-50
6.6 Other Connectors wiring.......................................................................................................................6-51
6.6.1 P3 PIB <-> ARTERIAL PRESSURE SENSOR ........................................................................6-51
6.6.2 P4 PIB <-> VENOUS PRESSURE SENSOR .........................................................................6-51
6.6.3 P3 HEP.PCB <-> SYRINGE LEVEL KEY ................................................................................6-51
6.6.4 BPRLY <-> BLOOD PUMP BOARD....................................................................................6-51
6.7 Power rack wiring (6957377) ...............................................................................................................6-52
6.7.1 TERMINAL BLOCKS <-> MAIN SWITCH...........................................................................6-52
6.7.2 HEATER RELAY <-> TERMINAL BLOCKS...........................................................................6-52
6.7.3 OPTOTRIAC <-> TERMINAL BLOCKS ...............................................................................6-52
6.7.4 Connector J2 OVERTEMP.....................................................................................................6-52
6.7.5 TRANSFORMER <-> TERMINAL BLOCKS .........................................................................6-53
6.7.6 J3 OVTEMP <-> TERMINAL BLOCKS .................................................................................6-53
6.7.7 J9 POWER SUPPLY <-> BATTERY .......................................................................................6-53
6.7.8 J8 POWER SUPPLY <-> MAIN SWITCH AUXIL. CONTACT .........................................6-53
6.8 Power rack wiring (6973432) ...............................................................................................................6-54
Rev. A
XVI PHOENIX SERVICE MANUAL: «MAINTENANCE»
6.8.1 Phoenix 115V ......................................................................................................................... 6-54
6.8.1.1 TERMINAL BLOCKS <-> MAIN SWITCH.........................................................6-54
6.8.1.2 TERMINAL BLOCKS <-> HEATER RELAY.........................................................6-54
6.8.1.3 TERMINAL BLOCKS <-> J3 OVTEMP ...............................................................6-54
6.8.1.4 OPTOTRIAC <-> TERMINAL BLOCKS and HEATER RELAY ........................6-54
6.8.1.5 J1 POWER SUPPLY <-> TERMINAL BLOCKS .................................................6-55
6.8.1.6 J8 POWER SUPPLY <-> MAIN SWITCH AUXIL. CONTACT .......................6-55
6.8.1.7 J9 POWER SUPPLY <-> BATTERY .....................................................................6-55
6.8.1.8 Connector J2 OVERTEMP...................................................................................6-55
6.8.1.9 POWER RACK GROUND CONNECTIONS ..................................................6-56
6.8.2 Phoenix 230V ......................................................................................................................... 6-57
6.8.2.1 TERMINAL BLOCKS <-> MAIN SWITCH.........................................................6-57
6.8.2.2 TERMINAL BLOCKS <-> HEATER RELAY.........................................................6-57
6.8.2.3 HEATER RELAY <-> OPTOTRIAC ......................................................................6-57
6.8.2.4 OPTOTRIAC <-> OPTOTRIAC...........................................................................6-57
6.8.2.5 TERMINAL BLOCKS <-> SWITCHING .............................................................6-58
6.8.2.6 HEATER RELAY <-> HEATER ASSEMBLY..........................................................6-58
6.8.2.7 OPTOTRIAC <-> HEATER ASSEMBLY ..............................................................6-58
6.8.2.8 J1 POWER SUPPLY <-> TERMINAL BLOCKS .................................................6-58
6.8.2.9 J1 POWER SUPPLY <-> MAIN SWITCH AUXIL. CONTACT .......................6-59
6.8.2.10 Connector J1 OVTEMP3<-> OPTOTRIAC ....................................................6-59
6.8.2.11 J9 POWER SUPPLY <-> BATTERY ...................................................................6-59
6.8.2.12 Connector J2 OVERTEMP3 <-> RELAY SOLENOID....................................6-59
6.8.2.13 POWER RACK GROUND CONNECTIONS ................................................6-60
6.9 Power Rack (6957377) cabling ........................................................................................................... 6-61
6.10 Power Rack (6973432) cabling ......................................................................................................... 6-61
6.10.1 Phoenix 115V ....................................................................................................................... 6-65
6.10.2 Phoenix 230V ....................................................................................................................... 6-69
7. SOFTWARE DESCRIPTION …………………………………………………………………………………………………………….7-1
7.1 Architecture overview ..............................................................................................................................7-1
7.2 Main Module RAM Tests .........................................................................................................................7-3
7.2.1 Power up memory test.............................................................................................................7-3
7.3 Protective Task ...........................................................................................................................................7-3
7.3.1 Data Input actions.....................................................................................................................7-3
7.3.2 Redundant data structures ......................................................................................................7-4
7.3.3 Redundant parameter modification.......................................................................................7-4
7.3.4 Messages generation................................................................................................................7-4
7.4 T1 Test..........................................................................................................................................................7-5
7.4.1 T1 Test Description...................................................................................................................7-8
8. CALIBRATIONS …………………………………………………………………………………………………………………………….8-1
8.1 CALIBRATION INTRODUCTION..........................................................................................................8-1
8.2 SOFTWARE CALIBRATION General Description...............................................................................8-3
8.2.1 Password.....................................................................................................................................8-3
8.2.2 CAL HOME page ......................................................................................................................8-4
8.2.3 “INFORMATION” Action Key................................................................................................8-5
8.2.4 “TEST” Action Key.....................................................................................................................8-6
8.2.5 “CALIBRATION” Action Key ..................................................................................................8-8
8.2.6 “AUTOCAL” Environment.................................................................................................... 8-10
8.2.7 “OPERATIONS” Environment.............................................................................................. 8-12
8.2.7.1 “SW UPGRADE” Action Key..............................................................................8-12
8.2.7.2 “CONFIG TRANSF” Action Key ........................................................................8-14
8.2.7.3 “MAIN SETTING” Action Key ............................................................................8-16
8.2.7.4 “DEFAULT COEFF” Action Key .........................................................................8-20
8.2.7.5 “RESTORING” Action Key..................................................................................8-21
8.2.7.6 “ACC. TESTING” Action Key..............................................................................8-22
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INTRODUCTION
XVII
8.3 Power Supply Verifications ...................................................................................................................8-24
8.4 R1 and R2 Pressure Regulators Calibration .......................................................................................8-26
8.5 CALIBRATION Procedures ...................................................................................................................8-28
8.5.1 PC PUMP .................................................................................................................................8-28
8.5.2 IN HD PRESSURE SENSOR (PI)...........................................................................................8-31
8.5.3 OUT HD PRESSURE SENSOR (PO)....................................................................................8-33
8.5.4 PFS PRESSURE SENSOR .......................................................................................................8-35
8.5.5 DRAIN PRESSURE SENSOR (PD)........................................................................................8-37
8.5.6 pH Probe..................................................................................................................................8-39
8.5.7 VEN PRESSURE SENSOR ......................................................................................................8-41
8.5.8 ART PRESSURE SENSOR ......................................................................................................8-43
8.5.9 T1T VEN PRESSURE ...............................................................................................................8-45
8.5.10 T1T ART PRESSURE .............................................................................................................8-47
8.5.11 PATIENT SENSOR LED........................................................................................................8-49
8.5.12 PATIENT SENSOR ................................................................................................................8-50
8.5.13 A CONDUCTIVITY ..............................................................................................................8-51
8.5.14 DIASCAN COND CELL ......................................................................................................8-54
8.5.15 B CONDUCTIVITY ..............................................................................................................8-56
8.5.16 D1 FLOW METER.................................................................................................................8-60
8.5.17 D2 Flow Meter......................................................................................................................8-62
8.5.18 P2 Pump.................................................................................................................................8-64
8.5.19 UF VESSEL..............................................................................................................................8-67
8.5.20 Temperature ..........................................................................................................................8-69
8.5.21 TOUCH SCREEN..................................................................................................................8-71
8.5.22 HDBPM PRESSURE SENSOR ............................................................................................8-72
8.5.23 HDBPM SAFETY SWITCH..................................................................................................8-74
8.6 Other Calibrations and Tests ................................................................................................................8-76
8.6.1 ABD SENSOR..........................................................................................................................8-76
8.6.2 BLD SENSOR...........................................................................................................................8-76
8.6.3 HDBPM on board accuracy test .........................................................................................8-76
8.7 SAFETY VALVE TEST PROCEDURE.....................................................................................................8-80
8.8 Autocalibration for PA pump, PB pump and UF pump ..................................................................8-81
8.8.1 Autocalibration Procedure for the Peristaltic Pumps During Dialysate
Preparation.........................................................................................................................................8-81
8.8.2 Autocalibration Procedure for the PA, PB Peristaltic Pumps during a Dialysis
Treatment ...........................................................................................................................................8-84
8.8.3 Autocalibration of the UF Pump..........................................................................................8-85
9. MAINTENANCE …………………………………………………………………………………………………………………………….9-1
9.1 General ....................................................................................................................................................... 9-1
9.2 PHOENIX Doors Opening/Closing Instructions ................................................................................. 9-1
9.2.1 Opening Instructions ............................................................................................................... 9-1
9.2.2 Closing Instructions .................................................................................................................. 9-1
9.3 Cleaning ...................................................................................................................................................... 9-2
9.3.1 Blood pump rotor cleaning..................................................................................................... 9-3
9.3.2 Removing the iron oxide deposits within the hydraulic flowpath with Oxalic
Acid........................................................................................................................................................ 9-4
9.4 Storage ........................................................................................................................................................ 9-6
9.4.1 Sealed Lead Battery storage ................................................................................................... 9-6
9.5 Periodic Safety Inspection ....................................................................................................................... 9-7
9.6 Preventive maintenance........................................................................................................................... 9-8
9.7 Emptying the machine.............................................................................................................................. 9-9
9.7.1 Disinfectant solution preparation .......................................................................................... 9-9
9.7.2 Chemical disinfection............................................................................................................... 9-9
9.7.3 Emptying the Phoenix by using a vacuum pump .............................................................9-10
9.7.4 Emptying the Phoenix without devices to drain water....................................................9-12
9.7.5 Restarting the machine after storage or shipment ...........................................................9-13
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PHOENIX SERVICE MANUAL: «MAINTENANCE»
10. SERVICE SCREEN & TROUBLESHOOTING …………………………………………………………………………………10-1
10.1 Service Screen: access view............................................................................................................... 10-1
10.2 Status Screen: First Page ..................................................................................................................... 10-4
10.2.1 First Page: Parameters description ................................................................................... 10-5
10.3 Status Screen: Second Page............................................................................................................... 10-8
10.3.1 Second Page: Parameter description............................................................................... 10-9
10.4 Status Screen: Third Page .................................................................................................................10-13
10.4.1 Third Page: Parameter description .................................................................................10-14
10.5 Status Screen: Coding Pages............................................................................................................10-17
10.5.1 Vismode FLAG ...................................................................................................................10-17
10.5.2 Vismode ONOFF...............................................................................................................10-17
10.5.3 Vismode REVONOFF .......................................................................................................10-17
10.5.4 Vismode LEVEL...................................................................................................................10-17
10.5.5 Vismode DOOR ................................................................................................................10-17
10.5.6 Vismode REVDOOR .........................................................................................................10-17
10.5.7 Vismode SET PUMPS........................................................................................................10-17
10.5.8 Vismode YESNO................................................................................................................10-18
10.5.9 Vismode REVYESNO ........................................................................................................10-18
10.5.10 Vismode HEXADEC ........................................................................................................10-18
10.5.11 Vismode DECIMAL .........................................................................................................10-33
10.6 Alarms and Signals .............................................................................................................................10-34
10.6.1 Classification and modes of intervention......................................................................10-34
10.6.2 Operator Guidelines for responding to Alarms on the Phoenix machine.............10-39
10.6.2.1 OVERRIDING Arterial and Venous Pressure Alarms ............................... 10-40
10.6.2.2 Operator Actions required after pressing the OVERRIDE Button
for Arterial and Venous Pressure Alarms.................................................................... 10-40
10.6.3 Alphabetic List of Alarms..................................................................................................10-41
10.6.4 Alarm description...............................................................................................................10-53
10.6.5 Numerical List of Alarms and Troubleshooting............................................................10-54
11. ADDITIONAL TROUBLESHOOTING TABLES ……………………………………………………………………………..11-1
11.1 Pi and Po Pressure sensor Test.......................................................................................................... 11-2
11.2 Mass Balance troubleshooting........................................................................................................... 11-5
11.3 General Safe state after communication alarms or after a bad Touchscreen
behaviour ........................................................................................................................................................ 11-9
11.4 Frozen Main Control Panel ..............................................................................................................11-14
11.5 BPM troubleshooting.........................................................................................................................11-15
12. SPECIAL CHECKOUT PROCEDURES ………………………………………………………………………………………….12-1
12.1 Blood Circuit Leakage Test................................................................................................................. 12-1
12.2 Venous Clamp Occlusion Test .......................................................................................................... 12-2
12.3 Blood Pump Rotor Occlusion Test ................................................................................................... 12-3
12.4 ABD Alarm Verification....................................................................................................................... 12-4
12.5 Blood Pump Cover position test....................................................................................................... 12-5
12.6 Venous Line Presence Sensor tests .................................................................................................. 12-6
12.7 Blood Pump Rotor positioning test .................................................................................................. 12-6
12.8 Leakage current Test............................................................................................................................ 12-6
12.9 Ground Integrity Test........................................................................................................................... 12-7
12.10 Power Failure & Battery Test ........................................................................................................... 12-7
12.11 Water Leakage Check....................................................................................................................... 12-9
12.12 WHO door sensor test ...................................................................................................................12-10
12.13 Total Ultrafiltration Accuracy Test ................................................................................................12-10
12.14 Mass Balance Test ...........................................................................................................................12-12
12.15 SWP Inlet Water Pressure Sensor Test ........................................................................................12-13
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13. SPARE PARTS LIST ……………………………………………………………………………………………………………………..13-1
13.1 Spare part list.........................................................................................................................................13-1
14. -INSTALLATION …………………………………………………………………………………………………………………………14-1
14.1 Required Equipment.............................................................................................................................14-1
14.2 Unpackaging instructions....................................................................................................................14-1
14.3 Setup For Checkout .............................................................................................................................14-1
14.4 Filling procedure ...................................................................................................................................14-3
14.5 R1, R2 and PC Calibrations.................................................................................................................14-4
14.6 Warming up the machine....................................................................................................................14-7
14.7 Test Procedures ....................................................................................................................................14-8
14.7.1 B CONDUCTIVITY ..............................................................................................................14-8
14.7.2 A CONDUCTIVITY ..............................................................................................................14-9
14.7.3 Diascan Cond Cell ............................................................................................................ 14-10
14.7.4 Temperature ....................................................................................................................... 14-10
14.7.5 Venous Pressure Sensor................................................................................................... 14-11
14.7.6 Arterial Pressure Sensor ................................................................................................... 14-12
14.7.7 Patient Sensor .................................................................................................................... 14-13
14.7.8 pH probe............................................................................................................................. 14-14
14.8 Parameters Configuration ................................................................................................................ 14-15
14.8.1 Manual Set.......................................................................................................................... 14-15
14.8.2 Configuring Multiple Machines ...................................................................................... 14-15
14.9 Preparing for a treatment ................................................................................................................. 14-16
14.10 Simulated Dialysis treatment......................................................................................................... 14-16
14.11 Electrical Safety Verification .......................................................................................................... 14-19
14.12 Disinfection....................................................................................................................................... 14-20
15. SPECIFICATIONS ………………………………………………………………………………………………………………………15-1
15.1 General specifications..........................................................................................................................15-1
15.2 Hydraulic section ..................................................................................................................................15-9
15.2.1 Water supply .........................................................................................................................15-9
15.2.2 Dialysate.............................................................................................................................. 15-10
15.2.3 Materials in contact with dialysate, concentrates and water.................................... 15-24
15.2.4 Descaling ............................................................................................................................ 15-24
15.2.5 Disinfection......................................................................................................................... 15-25
15.2.6 Ultrafiltration system......................................................................................................... 15-27
15.2.7 Detection of Extracorporeal Blood Loss ....................................................................... 15-28
15.2.8 Operating Modes.............................................................................................................. 15-30
15.3 Extracorporeal Circulation................................................................................................................ 15-33
15.3.1 Operating Modes.............................................................................................................. 15-33
15.3.2 Blood Pumps ...................................................................................................................... 15-35
15.3.3 Heparin pump.................................................................................................................... 15-37
15.3.4 Automatic Functions......................................................................................................... 15-38
15.3.5 Main Surveillance Devices .............................................................................................. 15-39
15.3.6 Safety system actuators.................................................................................................... 15-40
15.4 Protection System.............................................................................................................................. 15-41
15.5 General Safety Controls.................................................................................................................... 15-42
15.6 Estimate consumptions of the machine ........................................................................................ 15-44
WARRANTY ………………………………………………………………………………………………………………………………………….I
A. Appendix A: Guidelines and Manufacturer’s Declaration - Electromagnetic Emissions and
Immunity ........................................................................................................................................................... A-1
Rev. A
XX PHOENIX SERVICE MANUAL: «MAINTENANCE»
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Rev. A